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Provenge® (sipuleucel-T) (Intravenous)

Policy Number: VP-0100

Last Review Date: 04/06/2021

Date of Origin: 06/21/2011

Dates Reviewed: 09/2011, 12/2011, 03/2012, 06/2012, 09/2012, 11/2012, 12/2012, 03/2013, 06/2013, 09/2013, 12/2013, 03/2014, 06/2014, 09/2014, 12/2014, 03/2015, 05/2015, 08/2015, 11/2015, 02/2016, 05/2016, 08/2016, 11/2016, 02/2017, 05/2017, 08/2017, 11/2017, 02/2018, 05/2018, 04/2019, 04/2020, 04/2021

FOR PEEHIP Members Only -Coverage excludes the provider-administered medication(s) outlined in this drug policy from being accessed through a specialty pharmacy. It must be obtained through buy and bill.

I. Length of Authorization

Coverage will be provided for 3 doses only

II. Dosing Limits

  1. Quantity Limit (max daily dose) [NDC Unit]:
  • Provenge suspension for injection: 1 pre-made bag every 14 days for 3 doses only
  1. Max Units (per dose and over time) [HCPCS Unit]:
  • 1 billable unit every 14 days x 3 doses only

III. Initial Approval Criteria 1-4

Coverage is provided in the following conditions:

Prostate Cancer †

  • Patient has castration-resistant metastatic disease; AND
  • Patient has an ECOG Performance status of 0-1; AND
  • Patient has no hepatic metastases; AND
  • Must not be used in combination with chemotherapy; AND
  • Patient’s life expectancy is estimated to be greater than 6 months; AND
  • Patient is asymptomatic or minimally symptomatic; AND
  • Patient has not previously received therapy with sipuleucel-T

FDA Approved Indication(s); Compendia recommended indication(s)

IV. Renewal Criteria 1

Coverage cannot be renewed.

V. Dosage/Administration 1

Indication

Dose

Prostate Cancer

Infuse the contents of 1 pre-made bag (containing at least 50 million autologous CD54+ cells activated with PAP-GM-CSF) over 60 minutes. Administer 3 doses over approximately 2-week intervals

VI. Billing Code/Availability Information

HCPCS code:

  • Q2043 – Sipuleucel-T, minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF, including leukapheresis and all other preparatory procedures, per infusion
    • 1 billable unit = 1 dose (Code Price is per 250 mL)

NDC(s):

  • Provenge suspension for injection: 30237-8900-xx

VII. References

  1. Provenge [package insert]. Seal Beach, CA; Dendreon Pharmaceuticals LLC; July 2017. Accessed March 2021.
  2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for Sipuleucel-T. National Comprehensive Cancer Network, 2021. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc.” To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed March 2021.
  3. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for Prostate Cancer 2.2021. National Comprehensive Cancer Network, 2021. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc.” To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed March 2021.
  4. Kantoff PW, Higano CS, Shore ND, et al; IMPACT Study Investigators. Sipuleucel-T immunotherapy for castration-resistant prostate cancer. N Engl J Med. 2010 Jul 29;363(5):411-22. doi: 10.1056/NEJMoa1001294.
  5. Small EJ, Schellhammer PF, Higano CS, et al. Placebo-controlled phase III trial of immunologic therapy with sipuleucel-T (APC8015) in patients with metastatic, asymptomatic hormone refractory prostate cancer. J Clin Oncol. 2006 Jul 1;24(19):3089-94. doi: 10.1200/JCO.2005.04.5252.
  6. Noridian Healthcare Solutions, LLC. Local Coverage Article for SIPULEUCEL-T (Provenge®) - Coverage Criteria for Prostate Cancer – Clarification (A52926; A55719). Centers for Medicare & Medicaid Services, Inc. Updated on 09/29/2020 with effective date 10/19/2018. Accessed March 2021.
  7. National Coverage Determination (NCD) for Autologous Cellular Immunotherapy Treatment (110.22). Centers for Medicare & Medicaid Services, Inc. Updated 01/06/2012 with effective date 06/30/2011. Accessed March 2021.

Appendix 1 – Covered Diagnosis Codes

ICD-10

ICD-10 Description

C61

Malignant neoplasm of prostate

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determination (NCD), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs) may exist and compliance with these policies is required where applicable. They can be found at: http://www.cms.gov/medicare-coverage-database/search/advanced-search.aspx. Additional indications may be covered at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA):

Jurisdiction(s): E

NCD/LCD Document (s): A55719

https://www.cms.gov/medicare-coverage-database/search/document-id-search-results.aspx?Date=&DocID=A55719&SearchType=Advanced&bc=EgAAAAAAAAAA&

Jurisdiction(s): F

NCD/LCD Document (s): A52926

https://www.cms.gov/medicare-coverage-database/search/document-id-search-results.aspx?DocID=A52926&SearchType=Advanced&bc=EAAAAAAAAAAA&

Jurisdiction(s): ALL

NCD/LCD Document (s): NCD 110.22

https://www.cms.gov/medicare-coverage-database/search/document-id-search-results.aspx?DocID=110.22&bc=EAAAAAAAAAAA&&SearchType=Advanced

Medicare Part B Administrative Contractor (MAC) Jurisdictions

Jurisdiction

Applicable State/US Territory

Contractor

E (1)

CA, HI, NV, AS, GU, CNMI

Noridian Healthcare Solutions, LLC

F (2 & 3)

AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ

Noridian Healthcare Solutions, LLC

5

KS, NE, IA, MO

Wisconsin Physicians Service Insurance Corp (WPS)

6

MN, WI, IL

National Government Services, Inc. (NGS)

H (4 & 7)

LA, AR, MS, TX, OK, CO, NM

Novitas Solutions, Inc.

8

MI, IN

Wisconsin Physicians Service Insurance Corp (WPS)

N (9)

FL, PR, VI

First Coast Service Options, Inc.

J (10)

TN, GA, AL

Palmetto GBA, LLC

M (11)

NC, SC, WV, VA (excluding below)

Palmetto GBA, LLC

L (12)

DE, MD, PA, NJ, DC (includes Arlington & Fairfax counties and the city of Alexandria in VA)

Novitas Solutions, Inc.

K (13 & 14)

NY, CT, MA, RI, VT, ME, NH

National Government Services, Inc. (NGS)

15

KY, OH

CGS Administrators, LLC